Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia

Phase 2

Recruiting

• Conditions: Multiple Myeloma; Hypogammaglobulinemia; Hypogammaglobulinemia, Acquired
• Interventions: Drug: IgPro20

• Registration Number: NCT06976476
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The main purpose of this study is to see if IgPro20 can prevent infection in people with multiple myeloma (MM) who have hypogammaglobulinemia from receiving bispecific monoclonal antibodies (BsAbs).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-08
• Study First Submitted: 2025-05-08
• Study First Submitted QC: 2025-05-08
• Last Update Submitted: 2025-05-08
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Primary Completion: 2029-05-08
• Study Completion: 2029-05-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Diagnosis of RRMM receiving a commercially available bispecific antibody
• Received at least 1 but no more than 4 cycles of BsAb
• Received 2 or more lines of therapy for MM IgG ≤ 4 g/L excluding paraprotein. For IgG Kappa MM, hypogammaglobulinemia will be determined by subtracting the M spike from IgG
• Males or females greater than or equal to 18 years old at the time of consent
• ECOG ≤ 3
• Life expectancy > 12 months

Exclusion Criteria

• HSCT within 3 months before enrollment
• Planned CAR-T therapy in the next 6 months
• >1 major (deep-seated) infection within the preceding 3 months
• HIV infection, Active HCV, or Active HBV infection
• Pregnancy
• Neutrophils < 500 x 10^9 per mL, Platelets < 30 x 10^9 per mL
• History of cancer other than MM in the last 3 years requiring active chemotherapy or radiation
• Known reaction/allergy to IgG products
• Intracranial hemorrhage or embolic CVA in the last 6 months
• Hyperproteinemia
• Protein-losing enteropathy
• Creatinine Cl <30 ml/min
• Documented progression on BsAb
• Known history of Hyperprolinemia
• On current or previous IVIG (in the last 3 months)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care + IGRT prophylaxis with IgPro20	IgPro20	Participants will receive IGRT prophylaxis with IgPro20 in addition to standard of care

Primary Outcome Measures

Name	Time	Method
Difference in overall infection rates between Standard of Care participants and participants receiving IgPro20	6 months	To compare overall infection rates amongst (RR) multiple myeloma patients with hypogammaglobulinemia receiving subcutaneous immunoglobulin (IgPro20) to those in observational arm over a 6-month period.

Trial Locations

Locations (8)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activity); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities); 🇺🇸 Harrison, New York, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities); 🇺🇸 Uniondale, New York, United States